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Showing 1-20 of 91 trials
NCT04828083
The investigators are evaluating the postoperative outcomes in patients undergoing total knee arthroplasty that receive either systemic lidocaine or ultrasound-guided adductor canal block as part of their anesthetic plan.
NCT07456787
The purpose of this study is to evaluate the effectiveness of cryopressotherapy in patients undergoing total knee arthroplasty by assessing clinical improvement using the KOOS at 14 days after surgery. Analysis of the knee Range of Motion (ROM) in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery. Analysis of PROMs such as: Oxford Knee Score (OKS), Joint Forgotten (JF), NRS score, and SF-12. These questionnaires will be collected in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery. To evaluate whether cryopressotherapy leads to an improvement in predischarge hemoglobin (Hb) levels. To assess whether cryopressotherapy reduces the circumference and subcutaneous fluid accumulation of the operated limb.
NCT07442812
This prospective observational cohort study aims to evaluate the association between perioperative dexamethasone administration and early postoperative recovery following primary total knee arthroplasty. In routine clinical practice, dexamethasone may be administered orally, intravenously, or not administered, depending on the surgeon's established perioperative protocol. The primary objective is to assess early postoperative recovery in terms of pain intensity, functional mobility, and knee joint range of motion. Secondary objectives include evaluation of inflammatory response, postoperative metabolic changes, opioid requirement, and the severity of postoperative nausea and vomiting (PONV). Group allocation is non-randomized and determined solely by the standard perioperative management approach routinely applied by the surgeon selected by the patient. No additional interventions are introduced for research purposes. All outcomes are assessed prospectively during the early postoperative period.
NCT06089291
A prospective multicenter longitudinal cohort study of Zimmer Biomet (ZB) Persona IQ The Smart Knee which consists of the Persona Personalized Knee (PPK) System with mymobility® platform that is attempting to develop correlative measures to assist surgeons in understanding and managing risk in their patient populations. Specifically comparing kinematic metrics captured via Remote Therapeutic Monitoring (RTM) utilizing the CANARY canturio te (CTE) and canturio se (CSE) sensors in combination with the mymobility® App. The purpose of this study is to evaluate safety, functional performance, and effectiveness of the implant. Primary Objective: Assess Persona IQ kinematic metrics captured via the CTE/CSE sensor to assist surgeons in understanding and managing recovery through post-operative gait metrics. Secondary Objective: Evaluate the value of Remote Therapeutic Monitoring (RTM) and healthcare utilization. Exploratory Objective: Exploratory analyses will be performed using these data to direct future product feature development, data algorithm products, and research. This includes but is not limited to participants implanted utilizing ROSA® Robotics and other ZBEdge technologies.
NCT06929871
The overall aims of this prospective, randomised, single-blinded controlled trial are to compare functional, radiological and clinical outcomes in Mako robotic-arm assisted cementless Total Knee Arthroplasty (TKA) versus Mako robotic-arm assisted cemented TKA.
NCT03687593
The purpose of this research is to collect data on patients that had the Legion CR Oxinium and CoCr Femoral Implant and the Legion/Genesis II XLPE High Flex Tibial Inserts implanted in the past. Smith \& Nephew will evaluate the safety and performance of these implants.
NCT06908837
This trial aims to assess the analgesic effect of Popliteal Plexus Block (PPB) with 10 mL versus 20 mL of Bupivacain 5 mg/mL, when applied as an adjunct treatment to a multimodal analgesic regimen following primary total knee arthroplasty. We hypothesize that PPB with 20 mL of local anesthetic reduces 24-hour postoperative opioid consumption (= primary outcome) compared to 10 mL after TKA. Secondary outcome include * the frequency of 24-hour opioid-free analgesia * pain intensity at rest and during mobilization * Manual Muscle Tests and ability to mobilize with crutches six hours after end-of-surgery * and patients reported outcomes using the Quality of Recovery 15 survey 24 hours after end-of-surgery. Participant will: * undergo primary total knee arthroplasty in spinal anesthesia. * recieve a PPB with either 10 mL of Bupivacaine or 20 mL. * recieve a multimodal analgesic regime including a Femoral Triangle Block. * Have 10 scored morphine tablets available for self-administration within the first 24 postoperative hours after end-of-surgery. * be examined by a physiotherapist 6 hours (±1 hour) after end-of-surgery to assess pain scores, manual muscle testing of ankle and knee function, and the ability to mobilize with crutches. * complete a survey 24 hours after end-of-surgery to assess self-administered morphine intake, pain scores, and Quality of Recovery-15.
NCT06977191
This study aims to investigate whether heart rate variability (HRV), a marker of autonomic nervous system activity, can predict the occurrence of rebound pain after total knee arthroplasty (TKA). Rebound pain is defined as a sudden and intense pain episode (NRS ≥7) that typically arises after the resolution of peripheral nerve blocks used for postoperative analgesia. Patients undergoing elective unilateral TKA under spinal anesthesia with peripheral nerve blocks will be included. HRV will be measured both before and after surgery using a chest-worn heart rate monitor. Pain levels, analgesic consumption, sleep quality, and patient satisfaction will also be recorded. The primary goal is to determine whether perioperative HRV values can serve as a predictive biomarker for rebound pain. Secondary outcomes include the relationship between HRV and pain intensity, opioid use, sleep quality, and length of hospital stay. The findings may contribute to developing individualized pain management strategies for TKA patients.
NCT07347821
The aim of this observational study is to determine content of rare metals and other elements, along with the levels of selected immunological parameters, in the tissue of the hip or knee joint in the course of degenerative diseases. Determining potential disturbances in the levels or functions of these parameters may in the future contribute to improving treatment - for example, through supplementation of deficient metals or modulation at the immunological level. The main question it aims to answer is: Are selected rare metals, trace elements and other selected immunological parameters lowered in the tissue of the hip or knee joint as well as in serum in the course of osteoarthritis?
NCT05981105
The goal of this interventional clinical trial is to assess opioid consumption 24-48 hrs post anesthesia block among patients undergoing total knee arthroplasty. The main question it aims to answer is: 1\. Is there a difference in opioid consumption 24-48 hours post block administration among patients that receive an adductor canal catheter (ACC) versus adductor canal block (ACB)? Participants will be: * Randomized to receive an adductor canal catheter (ACC) or a sham adductor canal catheter. * Asked to use the Diagnotes application to communicate with the pain doctor while the catheter is in place. * Follow up for up to 6 months post-operation. Researchers will compare the interventional group (ACC) to the control group (sham ACC + ACB) to see if there is difference in opioid consumption and chronic pain at 6 months post-operation.
NCT07310303
This randomized controlled trial aims to evaluate the effect of simulation-based preoperative education on surgical fear and kinesiophobia in patients undergoing total knee arthroplasty. Eligible patients are randomly assigned to either a simulation-based education group or a standard verbal education (control) group. Surgical fear, kinesiophobia, and postoperative pain are assessed using validated measurement tools. The findings of this study are expected to contribute to evidence-based nursing practices by informing the development of effective preoperative education strategies to improve postoperative recovery outcomes.
NCT06968143
The main goal of this study is to see if there is a connection between the social and economic resources available in a patient's neighborhood (measured by the Area Deprivation Index, ADI) and their recovery after knee replacement surgery, as tracked through remote monitoring. A secondary goal is to find out if patients' self-reported pain and function score are linked to their actual physical improvement after surgery as measured by a remote therapeutic monitoring (RTM) device. Additionally, this study examines whether RTM can reduce the number of postoperative clinic visits within the first 90 days after surgery while maintaining patient satisfaction and patient-reported outcome measures (PROMs).
NCT06083480
This is a prospective randomized controlled trial that will assess preoperative, perioperative, and long-term oxidative stress (OS); pain; and functional outcomes over a 12 month period and test the hypothesis that a potent antioxidant intervention (glycine + N-acetyl-cysteine(GlyNAC)) reduces oxidative stress and chronic post surgical pain (CPSP) in patients undergoing total knee arthroplasty (TKA).
NCT06988033
Osteoarthritis (OA) is a chronic degenerative disease characterized by the destruction of articular cartilage, leading to functional impairment of surrounding bone and soft tissues. It is a major global public health problem, with the knee joint being the most commonly affected site. Treatment modalities include exercise, diet, oral non-steroidal anti-inflammatory drugs (NSAIDs), intra-articular injections, and total knee arthroplasty (TKA). TKA is indicated in cases of severe pain, functional loss, deformity, and limited range of motion when conservative methods are no longer effective. However, some patients may continue to experience deformity and functional deficits after surgery. Postoperative quadriceps weakness and decreased functional capacity can negatively affect patient prognosis. Following TKA, bone mineral density (BMD) tends to decrease during the first three months. The reduction in BMD and the increase in bone resorption may elevate the risk of implant loosening or periprosthetic fracture. Bone turnover markers (BTMs), which are enzymes or degradation products released into circulation by bone cells, reflect bone remodeling processes and can help identify increased fracture risk. A significant proportion of TKA candidates are osteopenic. Since osteopenic individuals make up a larger segment of the population, most fragility fractures actually occur in individuals with osteopenia rather than osteoporosis. Therefore, BMD levels and the presence of osteopenia or osteoporosis should be taken into account in patients undergoing TKA. To preserve both bone quality and muscle mass, early rehabilitation and progressive weight-bearing on the operated limb are considered essential. These strategies may improve both BMD and BTMs. Whole-body vibration (WBV) therapy has been suggested as an effective and safe method to increase mechanical loading on the bones. WBV can be applied in a static standing position on a vibration platform or combined with simultaneous exercise. Given the limited availability of targeted strategies to improve bone remodeling and BTMs after TKA, and the lack of clarity regarding the optimal WBV protocol, this study aims to investigate the effects of different vibration applications on bone turnover markers, functionality, muscle strength, pain intensity, pressure pain threshold, range of motion, proprioception, edema, and muscle biomechanical properties in osteopenic women following TKA. Participants will be randomly assigned to one of three groups: WBV only, WBV combined with exercise (WBV-E), or control. All groups will receive traditional rehabilitation three times per week for four weeks after surgery. WBV interventions will begin at the end of the fourth postoperative week, once patients are deemed ready. While WBV groups will receive additional vibration therapy, the control group will continue traditional rehabilitation alone. Outcomes will be evaluated using bone turnover markers, the Timed Up and Go (TUG) test, the 30-Second Chair Stand Test, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), measurements of muscle biomechanical properties and strength, pain intensity and pressure pain threshold, joint range of motion, proprioception, and edema.
NCT06678750
Evaluation of clinical outcomes and patient recovery in patients receiving TKA with traditional instrumentation systems compared to full arc of motion gap balancing using the Newton TM Knee Protocol
NCT07213622
The use of smart glasses for saphenous nerve adductor canal blocks compared to standard of care.
NCT06233435
This study is a prospective study which compares of Modified Post-Anesthetic Discharge Scoring System (PADSS) between 6 and 24 hours in patients undergoing total knee arthroplasty in Thammasat University hospital, Thailand.
NCT04199780
The purpose of this study is to determine whether a new medical technology can help reduce post-operative total knee or hip pain when combined with a Cognitive-Behavioral intervention (CBI). This new medical technology, is called transcranial direct current stimulation (tDCS), it uses a very small amount of electricity to temporarily stimulate specific areas of the brain thought to be involved in pain reduction. The electrical current passes through the skin, scalp, hair, and skull and requires no additional medication, sedation, or needles. This study will investigate the effects of tDCS, the Cognitive-Behavioral (CB) intervention and their combination on pain among veterans following total knee arthroplasty (TKA) or total hip arthroplasty (THA). The Veteran may benefit in the form of decreased pain and opioid requirements following knee or hip replacement surgery. However, benefit is only likely if Veterans are randomized to one of the 3 (out of 4) groups. This study hopes to determine the effects of these interventions and combined effect on post-operative pain, opioid use and functioning during the 48-hour post-operative period following a total knee or hip replacement.
NCT05391828
A randomized, controlled study comparing two total knee implant devices, Persona medial congruent (MC) vs posterior stabilized (PS). These surgeries will be performed using the ROSA robotic system. Patients will be followed up to 5 years.
NCT07080814
Total knee arthroplasty (TKA) is a common surgery used to treat advanced knee osteoarthritis, especially when other treatments no longer help. While the surgery often reduces pain and improves joint alignment, many patients still have problems with balance and movement afterward. This study will explore whether adding balance training using the Tecnobody ProKin system to standard physical therapy helps patients recover better after TKA. The researchers will measure balance, walking ability, leg strength, and body awareness (also called proprioception) using special equipment. The main goal is to test the hypothesis that technology-supported balance training improves recovery outcomes more effectively than standard rehabilitation alone.